First human experience of thermal arterial closure

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Interventional Cardiology

Background:

• Current femoral artery closure methods (collagen plugs, sutures) have significant vascular complication rates.
• The CardioDex device offers a novel approach using thermal energy for hemostasis.
• This technology aims to improve safety and efficacy in percutaneous cardiac catheterization procedures.

Purpose of the Study:

• To evaluate the safety and efficacy of the CardioDex arterial closure device.
• To assess the device's performance in patients undergoing percutaneous cardiac catheterization.
• To determine time to hemostasis and ambulation, and short-term clinical outcomes.

Main Methods:

• Prospective, nonrandomized, single-center trial involving 34 patients undergoing 6F cardiac procedures.
• Immediate femoral artery puncture closure with the CardioDex device, followed by brief manual compression.
• Collection of data on time to hemostasis (TTH), time to ambulation (TTA), and short-term follow-up.

Main Results:

• Median TTH was 3 min for diagnostic and 4 min for interventional cases, independent of activated clotting time (ACT).
• Median TTA was 2.75 hr (diagnostic) and 3.37 hr (interventional).
• No major adverse events were observed at 1-week and 30-day follow-up.

Conclusions:

• The CardioDex closure device is safe and effective in a small cohort for diagnostic and interventional cardiac catheterization.
• The device is suitable for patients on mild anticoagulation, with a mean ACT of 188 sec.
• A key advantage is the absence of foreign material left in the body post-procedure.